Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Not applicable. Healthy Volunteers
Key facts
- Sponsor
- Taiho Oncology Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 23 Oct 2023 → 23 Dec 2023
- Decision date (initial)
- 2023-10-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable. Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Taiho Oncology Inc.
- Sponsor organisation
- Taiho Oncology Inc.
- Address
- 101 Carnegie Center Suite 101
- City
- Princeton
- Postcode
- 08540-6231
- Country
- United States
Scientific contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Taiho Oncology, Inc.
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Taiho Oncology, Inc.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-10-23 | 2023-12-22 | 2023-11-09 | 2023-12-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-31 | Germany | Acceptable 2023-10-17
|
2023-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Germany | Acceptable 2024-10-10
|
2024-10-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-28 | Germany | Acceptable 2024-11-21
|
2024-11-22 |